The ActiControl study is a monocentric, academic, and fully remote observational study designed to build a normative, longitudinal dataset using the Syde® wearable device. The study will enroll 200 healthy volunteers across all age groups, genders, and backgrounds. Participants will be remotely recruited and followed over two years, wearing the Syde® device for 3-week periods every 6 months. All study visits, including consent, data collection, and follow-up, are conducted remotely via phone or video conferencing. The primary objectives are to collect reference data on gait and movement patterns and to assess adherence and acceptability of the device. Secondary objectives include evaluating the reliability of digital endpoints and the influence of demographic and lifestyle factors on these measures.
Male and female of different age groups
Signed informed consent form by participant him/herself or, in case of patients <18 years old, signed informed consent form by patient's parents or legal guardians
Able to ambulate (minimum 10 meters without help)
Participant willing and able to comply with all study procedures
Patients who have undergone a surgical procedure or who have experienced recent trauma (within fewer than 6 months) affecting the upper or lower limbs
Elite athletes (at the national level)
Pregnant women
A chronic or acute muscular, neurological, infectious, or inflammatory pathology within the 3-week period immediately prior to inclusion
Single group
Syde
DeviceSyde is an innovative device intended to be used in a home-based environment. It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle.
Post-recording questionnaire
Other interventionThe post-recording questionnaire aims at describing as much as possible the subject activity and quality of life during the recording period while being as low a burden as possible for the subject. The question formats are, on one hand, inspired by Quality of life and Physical Activity questionnaires usually used in Clinical Research and, on the other hand, based on device-specific needs for an optimal analysis. It covers fatigue status, physical status, physical activity with the Syde®, event(s) or condition(s) that may have impacted the ability to wear the Syde® during the recording.
Digital Mobility Monitoring Compliance
Measure of participant adherence to wearing the Syde® device using different parameters including total recording time, number of valid recording days (≥4 hours), and time to reach 50 and 180 hours of recording.
Walking Pattern Characteristics
Analysis of walking sequences, including maximal walking sequence duration, maximal distance walked in a single sequence, and maximal 30-minute walking distance.
Device Acceptability and Adherence
Measures of user engagement with the Syde® device across age groups and over time, including total recording time, valid days (≥5 hours), and time to reach 50 and 180 hours.
Reliability of Digital Variables
Test-retest reliability of Syde® digital variables assessed using intraclass correlation coefficients (ICC) between two consecutive half-periods.
Association with Demographic and Health Factors
Correlation of digital mobility outcomes with age, height, weight, BMI, and other demographic or health-related variables.
Group Differences in Digital Variables
Comparison of digital mobility metrics across subgroups defined by gender, age, health status, education, socio-professional category, physical activity level, living environment, and seasonality.
Click on the lead sponsor to view all of their trials.
Centre Hospitalier Universitaire de Liege
Lead sponsor
Centre Hospitalier Régional de la Citadelle
Collaborator
SYSNAV
Collaborator
